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Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy — VALIANTSMA  

Spinal Muscular Atrophy Clinical Trial

Official title:
Prospective Controlled Trial of Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy (VALIANTSMA) Study

Clinical Trial Summary

The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients.

Clinical Trial Description

Participation in this study entails six visits and seven to eight blood draws over 13 months. Each visit entails a stay of two days and one night at the General Clinical Research Center (GCRC).

Subjects who live within driving distance will be allowed to participate in the study without an overnight stay through two consecutive outpatient visits. All subjects will be evaluated at two screening visits 2-4 weeks apart to determine eligibility for participation. Eligible subjects will be randomized to receive VPA or placebo for the first six months. At the six-month visit, patients will be evaluated and crossed over to the other regimen. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00481013
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 2
Start date July 2007
Completion date November 2010
View Details
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